NCT00139971Unknown3 期
Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer
West Japan Thoracic Oncology Group2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2001年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- 5 year survival rate
研究概览
简要总结
To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •completely resected non small cell lung cancer
- •no prior anti cancer treatment for thoracic malignancy exept for this operation
- •pathological stage IB, II, and stage IIIA with only one station of n2 disease
- •adequate organ function for chemotherapy
- •written informed consent
排除标准
- •small cell lung cancer or low grade malignancy of lung cancer
- •incomplete resection
- •apparent interstitial pneumonitis at chest rentogenogram
- •inadequate condition for chemotherapy
结局指标
主要结局
5 year survival rate
次要结局
- Disease free survival
研究者
研究点 (2)
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